Acuerdo 0185-ARSA-2025
Acuerdo 0185-ARSA-2025 is the official ARSA identifier for “Reglamento de Tecnovigilancia”. Acuerdo 0185-ARSA-2025 is the official identifier ARSA uses for this instrument.
- Instrument
- Acuerdo
- Full name
- Acuerdo 0185-ARSA-2025
- Category
- Vigilance
- Source publication
- Spanish
- Readable HTML
- 1 language version
- Published
- 2025-09-29
- Effective
- —
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Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Reglamento de Tecnovigilancia
Complete 16-page Gazette original, signed 7 August 2025 and published 29 September 2025 in La Gaceta 36954. Contains 29 articles covering the national technovigilance system, responsible contacts, reporting, immediate and periodic notifications, safety actions, falsified/substandard devices, confidentiality and sanctions. Commences twenty days after Gazette publication. Each Gazette column is read in sequence.
Acuerdo 0185-ARSA-2025 is the official identifier ARSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.